AzTrials
AzTrials

Respiratory Syncytial Virus InfectionsPhase 1NCT01968083

Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children

A Phase 1 study testing RSV cps2 Vaccine in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children. This study will evaluate the safety and immune response to an RSV vaccine in healthy RSV-naïve children. Read more about this study

Who is it for?
Ages 6 to 24 monthsHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
RSV cps2 Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
5 sitesUnited States
Study dates
3 Oct 2013to May 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Parents/guardians who demonstrate their understanding of the study (by taking a multiple choice questionnaire), sign the informed consent, and agree to vaccine administration following detailed explanation of the study
  • Seronegative for RSV antibody, defined as a serum RSV neutralizing antibody titer less than 1:40 as determined within 42 days prior to enrollment/immunization
  • Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health
  • In the view of the site investigator, the participant has received routine immunizations appropriate for their age
  • Participant is expected to be available for the duration of the study
  • For children born to HIV-infected women: two negative polymerase chain reaction (PCR) tests with one collected when greater than 1 month of age and one collected when greater than 4 months old, and no positive HIV PCR test; or two negative HIV antibody tests

Who cannot join

  • Known or suspected impairment of immunological functions or HIV infection
  • Receipt of immunosuppressive therapy including systemic corticosteroids within 30 days of study entry. NOTE: Topical steroids, topical antibiotic, and topical antifungal medications are acceptable within 24 hours of enrollment. May be reassessed after symptoms have resolved.
  • Bone marrow/solid organ transplant recipients
  • Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
  • Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product
  • Previous serious vaccine-associated AE or anaphylactic reaction
Show all 17Show fewer
  • Known hypersensitivity to any vaccine component
  • Lung or heart disease, including any wheezing event or reactive airway disease. Participants with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. Participants who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
  • Member of a household that includes an infant less than 6 months of age
  • Member of a household that contains an immunocompromised individual (including, but not limited to: those with HIV-related immunodeficiency, defined as CD4 less than 300, or less than 15% if less than 5 years of age, measured within the previous 6 months; or any household members who have received chemotherapy within the last 12 months). Verbal report is sufficient documentation if the parent/guardian is confident of history.
  • Attends day care with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
  • Fever (rectal temperature of greater than or equal to 100.4°F [38°C]), or upper respiratory illness (rhinorrhea, cough, or pharyngitis) or nasal congestion significant enough to interfere with successful vaccination, or otitis media
  • Participant has received any killed vaccine or live attenuated rotavirus vaccine within the last 2 weeks, any other live vaccine within the last 4 weeks, or gamma globulin (or other antibody products) within the past 3 months, or is scheduled to receive any immunization in the 28 days after enrollment
  • Receipt of another investigational vaccine or investigational drug within 28 days of receiving this investigational RSV vaccine
  • Participant has received antibiotics or systemic or nasal steroid therapy or other prescription medications for acute illness within 3 days of study entry. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) topical steroids, topical antibiotics, and topical antifungal agents.
  • Participant has received salicylate (aspirin) or salicylate-containing products within the past month
  • Infants born at less than 37 weeks gestation and less than 1 year of age

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Rush Univ. Cook County Hosp. Chicago NICHD CRS

    Chicago, Illinois, 60612

  • Chicago Children's CRS

    Chicago, Illinois, 60614-3393

  • The Children's Hospital University of Colorado

    Denver, Colorado, 80045

  • University of California, UC San Diego CRS

    La Jolla, California, 92093-0672

  • Miller Children's Hospital at Long Beach Memorial Medical Center

    Long Beach, California, 90806

Other trials in United States

About this study

Official title: A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children. This study will evaluate the safety and immune response to an RSV vaccine in healthy RSV-naïve children.

Read the detailed description

RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age around the world. RSV illness can range from mild upper respiratory tract illness (URI) to severe LRI, including bronchiolitis and pneumonia. This study will evaluate the safety and immunogenicity of an RSV vaccine in healthy RSV-naïve children.

At study entry, participants will undergo a medical history review, physical examination, blood collection, and a nasal wash. Participants will be randomly assigned to receive the RSV vaccine or placebo at a 2:1 ratio, to be administered as nose drops. Participants will be actively monitored for 28 days following administration of vaccine or placebo; monitoring will include medical history reviews, clinical assessments, and at some visits, nasal washes. On the days when no study visit is scheduled, study researchers will contact participants' parents or guardians for medical follow-up. At a study visit on Day 56, participants will undergo a medical history review, blood collection, and a nasal wash procedure.

From November through March following each participant's study participation, parents or guardians will report respiratory and/or febrile illnesses on a weekly basis via telephone calls to study researchers. Participants may have additional study visits that may include blood collection and/or nasal wash procedures during this follow-up period.

This protocol is a companion study to CIR 285; a study being conducted by the Center for Immunization Research (CIR, Johns Hopkins, Baltimore), and the Laboratory of Infectious Diseases (NIAID, Bethesda). The protocols have identical primary and secondary objectives; immunization schedules; evaluation assays and schedules; safety monitoring and reporting. The protocols will vary slightly in site selection requirements, eligibility requirements and site monitoring. These are all operational issues modified to account for the IMPAACT sites' operations and infrastructure.

Being tested
RSV cps2 Vaccine, Placebo Vaccine
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSV cps2 VaccineBiological

    10^5.3 plaque forming units (PFUs) or RSV cps2 vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).

  • Placebo VaccineBiological

    Placebo vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).

Study groups in NCT01968083
Study groupRoleWhat they receive
RSV cps2 VaccineExperimentalParticipants will receive one dose of the RSV cps2 vaccine administered as nose drops at study entry.
Receives: Biological: RSV cps2 Vaccine
PlaceboPlacebo comparatorParticipants will receive one dose of placebo administered as nose drops at study entry.
Receives: Biological: Placebo Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (Days 0-28)

    Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (Days 0-28)

    Measured: Measured through Day 28

  2. Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination

    Antibody responses to the RSV F glycoprotein will also be assessed by enzyme-linked immunosorbent assay (ELISA).

    Measured: Measured through study follow-up period, up to 1 year after study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2013 (estimated)
  2. Study start3 Oct 2013
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01968083
Sponsor's protocol ID
P1114
Other IDs
11948
Status last verified
Jan 2017
First submitted
18 Oct 2013
Last updated
26 Jul 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Buchholz UJ, Cunningham CK, Muresan P, Gnanashanmugam D, Sato P, Siberry GK, Rexroad V, Valentine M, Perlowski C, Schappell E, Thumar B, Luongo C, Barr E, Aziz M, Yogev R, Spector SA, Collins PL, McFarland EJ, Karron RA; International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1114 Study Team. Live Respiratory Syncytial Virus (RSV) Vaccine Candidate Containing Stabilized Temperature-Sensitivity Mutations Is Highly Attenuated in RSV-Seronegative Infants and Children. J Infect Dis. 2018 Apr 11;217(9):1338-1346. doi: 10.1093/infdis/jiy066.

    PubMed 29509929

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RSV cps2 Vaccine in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (Days 0-28) (time frame: Measured through Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01968083, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in